Meningococcal group B vaccine Pregnancy Warnings

Comments:-Vaccination should not be withheld when there is a clear risk of meningococcal exposure.

Animal studies did not show impaired fertility or harm to the fetus. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to Bexsero(R), a pregnancy registry has been established in the US. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-683-4732.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Meningococcal group B vaccine Breastfeeding Warnings

Animal studies did not show adverse reactions in mothers or offspring through day 29 of lactation; immunogenicity was seen in mothers vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined.

Use with caution

Excreted into human milk: UnknownExcreted into animal milk: Data not available

Comments:-Evaluate risk to benefit before vaccinating women who are breast feeding.